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Merck Serono puts faith in lung cancer candidate

Continues tecemotide development despite underwhelming phase III results

Merck Serono Geneva HQ

Merck Serono has decided to continue development of its tecemotide immunotherapy for non-small cell lung cancer (NSCLC) despite disappointing results in a phase III trial.

The results of the START study found that tecemotide was unable to improve overall survival in patients with unresectable stage III NSCLC, the primary endpoint in the trial.

A single case of fatal encephalitis during the trial of tecemotide in with multiple myeloma prompted a temporary clinical hold to be place on it, calling a halt to the study trial mid-way through, and it's thought this may have impacted the results.

A subsequent analysis suggested however that the immunotherapy did lend a survival edge to a subgroup of patients given uninterrupted tecemotide as a maintenance therapy when compared to placebo on top of conventional chemotherapy.

Merck Serono said yesterday that patients in this subgroup achieved a median overall survival of 30.8 months versus 20.6 months in patients treated with placebo.

That level of benefit has not been observed in any other investigational treatment for unresectable stage III NSCLC, according to Dr Charles Butts of the University of Alberta in Canada, a member of the START trial's steering committee.

"The START data delivered important insights that we believe justify further investigation in a new phase III programme," commented Merck Serono's head of global drug development Dr Annalisa Jenkins.

"NSCLC is a devastating disease, and we are pleased to be able to continue supporting innovation in this important emerging field of immuno-oncology," she added.

Tecemotide (formerly known as Stimuvax and L-BLP25) is an immunotherapy based on MUC1, a glycoprotein antigen that is expressed on various tumour cell types, including NSCLC.

Merck Serono said it will now begin a second phase III trial of tecemotide - called START2 - that will enrol around 1,000 patients with unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum-based concurrent chemoradiotherapy (CRT).

The company licensed the immunotherapy in 2007 from US pharma company Oncothyreon, which is also developing a follow-up vaccine targetting MUC1 - called ONT-10 - that is not licensed to Merck Serono and is currently in phase I testing.

The decision to press on with tecemotide comes after Merck Serono has suffered other setbacks in its late-stage pipeline, notably an attempt to extend the indications for cancer drug Erbitux (cetuximab) into NSCLC and the failure of multiple sclerosis candidate cladribine.

Article by
Phil Taylor

26th September 2013

From: Research

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